
FDA•CRITICAL
Relax 5-HTP Plus Vitamin B6
Relax 5-HTP Plus Vitamin B6 recalled for elevated 5-HTP levels above allowed dosage.
2 products
Relax 5-HTP Plus Vitamin B6 recalled for elevated 5-HTP levels above allowed dosage.
2 products
Baxter recalls Cefazolin in Dextrose 2g/100mL infusion bags due to particulate matter.

American Regent recalls Nitroglycerin Injection 50 mg/10 mL and other injectables due to particulate matter (hair).
14 products
Micro Labs recalls Dorzolamide HCl/Timolol Maleate 2%/0.5% 10mL ophthalmic solution due to defective container caps.

Ascend recalls Dabigatran Etexilate 75mg/150mg capsules over impurity spec failures.
6 products
Mylan recalls Mycophenolate Mofetil for Injection 500 mg/vial due to precipitate.
2 products
Argon recalls L-Cath PICC catheters over hub leak/crack risk.
2 products
Windstone Medical recalls AMS medical convenience kits due to potential endotoxin variability in included sponges.
6 products
Romorgniz 12-drawer fabric dressers recalled for tip-over and entrapment hazards; violate STURDY Act.

Aojieni Silicone pull string teething toys violate toy standard; strings pose deadly choking hazard.

YouRfocus recalls CuddleCubs Creations teething toy sets due to choking hazard from silicone pull strings.

EnHomee 9-Drawer Fabric Dressers recalled for tip-over and entrapment hazards; violates STURDY Act; sold on Walmart.com.

Yuanxinxiang recalls OeyUoc pool drain covers over VGBA violation posing entrapment and drowning hazards.

Peony Design recalls baby bibs and stroller bags due to choking hazard from detaching snaps.

Sviyatp pool drain covers violate VGBA entrapment standards, posing drowning hazards.

Fresenius Kabi recalls injectables due to hair particulate matter.
5 products
Rohto Cooling Eye Drops recalled over sterility concerns; multiple formulations affected.
8 products
Precision Dose recalls Glycopyrrolate Oral Solution 1 mg/5 mL over an impurity.
3 products
Medline is recalling convenience kits containing BD PurPrep 26 mL over possible Bacillus contamination.
4 products
Medline recalls convenience kits with Bard Silastic Foley Catheters (sizes 16, 18, 20) due to surface raw material risk.
9 products
Medtronic MiniMed recalls MiniMed Go App v1.0.0 and v1.1.0 over nighttime alert failure risking missed insulin doses.

Karl Storz recalls hysteroscope kits with expired endoscopic seals that may compromise sterility.

Alphatec Spine recalls SafeOp Patient Interface over software issue causing tEMG loss, system faults, and reboot prompts.

Kent Imaging recalls SnapshotGLO wound imaging devices due to battery charging failure.

Micro Therapeutics recalls Pipeline Flex Embolization Devices due to incorrect labeling of implant sizes.
4 products
Medline is recalling anterior hip kits containing Bupivacaine Hydrochloride in Dextrose Injection over quality issues.
4 products
AVID Medical recalls Halyard Standard Line Insertion Pack (Model PVHM234-01) over silicone seal defects causing leakage.
Emano Flow v2.0.0 recalled due to audio sampling mismatch causing biased flow rate and volume estimates.

Boston Scientific recalls TheraSphere 360 Y-90 Platform due to software anomaly causing incorrect dose calculations.

Olympus recalls UHI-4 insufflation unit over unexpected display shutdown and air delivery loss.

Medtronic is recalling the Ventriculostomy Kit due to endotoxin levels that exceed safety limits for cerebrospinal fluid contact.

Penumbra is recalling the RED 68 Reperfusion Catheter due to a manufacturing issue that may cause the device to fracture during use.

Wilcox is recalling all BOSS Xe aiming lasers to implement a safety-related software enhancement.
3mensio software may report inaccurate cardiovascular measurements when analyzing specific Philips 3D echo datasets.

The Silent Nite Sleep Appliance (Model SILNT) is being recalled because it lacks required FDA clearance.

Olympus is recalling the 4K UHD LCD Monitor (model OEV321UH) due to a potential connector fault that may cause image loss or abnormalities.

AVID Medical is recalling the Eye Pack convenience kit (Model LVEY27) due to an incorrect concentration of Betadine solution.

SeaSpine is recalling the Polyaxial Head due to a manufacturing error that may cause the component to detach during surgery.

Rising Pharma recalls Cetirizine HCl 5 mg tablets due to ranitidine cross-contamination.

Taylor Farms recalls 21 lettuce products over Cyclospora risk.
21 products
Cat & Jack children's sandals are recalled due to a choking hazard from detachable pearls on the footwear.

Rising Pharma recalls Cyproheptadine HCl Syrup 2mg/5 mL due to crystallization and floating particles.

Major Pharmaceuticals recalls Levothyroxine 25 mcg tablets due to subpotency.
12 products
Ascend Laboratories is recalling Amlodipine and Olmesartan Medoxomil Tablets (10 mg/20 mg) due to failed dissolution specifications.

Supernus recalls Trokendi XR 25mg capsules over failed dissolution specs.
3 products
Ascend recalls Dabigatran etexilate capsules (110 mg, 150 mg) over impurity test failures.
2 products
Bionpharma recalls Divalproex Sodium 500 mg tablets due to foreign tablets/capsules.

Ferno is recalling the Power F2 Powered Fastening System due to a risk of the rail mechanism lodging and preventing stretcher movement.

ICU Medical is recalling Hotline Fluid Warming Sets due to a risk of leakage at the tubing-to-connector bond.

Paragon 28 is recalling the Phantom Hindfoot TTC/TC Ball Tipped Guide Rod (item P31-955-1800-S) due to sterile packaging breaches.
